QA Specialist I
QA Specialist I
United States - California - Oceanside
Gilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gileads therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.
Making an impact on a global scale
Inclusion is one of the companys five core values. Thats because we know that we are stronger and more innovative at Gilead when we are informed by a diverse set of backgrounds, experiences and points of view. Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide.
When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives. Come join a mission-driven bio-pharmaceutical organization that values inclusion and diversity, has a strong portfolio of products, and is constantly #CreatingPossible
Gilead Sciences, Inc. is a research-based biopharmaceutical company founded in 1987. Together we deliver life-saving therapies to patients in need. With the commitment and drive you bring to the workplace every day, you will be part of a team that is changing the world and helping millions of people live healthier, more fulfilling lives. Our worldwide staff is a close community where you can see the tangible results of your contributions, where every individual matters, and everyone has a chance to enhance their skills through ongoing development. Our scientific focus has resulted in marketed products that are benefiting hundreds of thousands of people, a pipeline of late-stage drug candidates, and unmatched patient access programs to ensure medications are available to those who could otherwise not afford them. By joining Gilead, you will further our mission to address unmet medical needs and improve life by advancing the care of patients with life-threatening diseases.
QA Specialist I
- Perform Quality Assurance activities to ensure compliance with internal processes and procedures and applicable US and international regulatory requirements in support of current Good Manufacturing Practices (cGMP) operations.
- Maintain routine systems, programs, and processes to ensure high quality products and compliance with current Good Manufacturing Practices (cGMP).
- Review manufacturing batch records, executed batch records, and supporting documents for Biologics Drug Substance and Drug Product lot disposition.
- Develop solutions to more complex problems and identifies deviations from accepted practice and evaluates impact assessment as required.
- May assist with compliance audits as required.
- Maintain electronic records and paper archives (e.g, lot history records, reports, data).
- Process deviations, investigations, and corrective and preventive action (CAPA) activities related to manufactured products.
- Effectively communicate with external suppliers as part of the batch record review function to address documentation and compliance issues.
- Participates in changes to controlled documents (e.g., SOPs, specifications, methods, etc.) as needed.
- Receives general instructions on routine work, detailed instructions on new assignments.
- With guidance, may work with Research and Development during new product start-ups.
- Other responsibilities and duties as assigned.
- Relevant working knowledge of current Good Manufacturing Practices (cGMP) regulations, quality assurance principles, systems, and industry practices.
- Must have critical thinking ability to exercise judgment within defined procedures and acceptable practices to determine appropriate action based on quality assessments and available data.
- Must recognize deviations from accepted practices.
- Be able to work independently and efficiently on routine work and can undertake more complex assignments with general guidance.
- Good verbal, written, and interpersonal communication skills are required.
- Demonstrates working knowledge in Microsoft Office applications.
Typical Education & Experience
- 2+ years of relevant experience in a GMP environment related field and a BS OR 3+ years of relevant experience and an AA degree.
- Prior experience in pharmaceutical industry is beneficial.
For jobs in the United States:
As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact firstname.lastname@example.org for assistance.
For more information about equal employment opportunity protections, please view the EEO is the Law' poster.
NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT
PAY TRANSPARENCY NONDISCRIMINATION PROVISION
Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.
Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.
For Current Gilead Employees and Contractors:
Please log onto your Internal Career Site to apply for this job.
To apply, visit https://gilead.wd1.myworkdayjobs.com/en-US/gileadcareers/job/United-States---California---Oceanside/QA-Specialist-I_R0021525-2
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